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Background: Probiotic supplementation to women during pregnancy and lactation can modulate breast milk composition, with immune benefits being transferred to their infants. Aim: The aim of the study was to evaluate the effect of high-dose probiotic supplementation to women during late pregnancy and lactation on cytokine profile and secretory IgA (sIgA) in breast milk and thus to study if differences in breast milk composition can affect lactoferrin and sIgA levels in stool samples of newborns. The safety of maternal probiotic administration on neonatal growth pattern and gastrointestinal symptoms were also evaluated. Methods: In a double-blind, placebo-controlled, randomized trial, 66 women took either the probiotic (n = 33) or a placebo (n = 33) daily. Levels of interleukins (IL-6, IL-10 and IL-1β), transforming growth factor-β1 (TGF-β1), and sIgA in breast milk; and the level of sIgA and lactoferrin in newborn stool samples were analyzed at birth and then again at one month of life. Antropometrical evaluation and analysis of gastrointestinal events in newborns was also performed. Results: Probiotic maternal consumption had a significant impact on IL6 mean values in colostrum and on IL10 and TGF-β1 mean values in mature breast milk. Fecal sIgA mean values were higher in newborns whose mothers took the probiotic product than in the control group. Probiotic maternal supplementation seems to decrease incidence of infantile colic and regurgitation in infants. Conclusion: High-dose multi-strain probiotic administration to women during pregnancy influences breast milk cytokines pattern and sIgA production in newborns, and seems to improve gastrointestinal functional symptoms in infants.

Infant colic, excessive crying of unknown cause, is a major burden to families and effects about 10–30 % of infants. Despite decades of research, the exact cause and treatment of infant colic has remained elusive. The use of Lactobacillus reuteri (DSM 17938) in infant colic is somewhat controversial and hence, we designed this study to evaluate its efficacy in infantile colic. We recruited predominantly or exclusively breastfed infants, aged less than 4 months in a placebo controlled observational randomized study. Participants’ were assigned to receive L. reuteri at a dose 10 8 colony forming units (n = 21) and placebo (n = 21). Placebo was an identical formulation without live micro-organisms. Treatment was given to subjects for 21 days and they were followed for 4 weeks. Treatment success (primary outcome), daily reduction in crying time, parent satisfaction and reduction in maternal depression (secondary outcomes) were assessed at the end of study period. Treatment success was observed in all infants (100 %) of the probiotic group while it was seen in 15.7 % of the placebo group. Mean daily crying time was more significantly reduced to 32.1 ± 8.3 min/day (P < 0.01) from 200.9 ± 6.3 min/day in the probiotic group as compared to the placebo group (120.6 ± 20.0 min/day). Moreover, throughout the study period, parent’s satisfaction and improvement in maternal depression (Edinburgh postnatal depression scale) was also significantly higher in the probiotic group. In our study population, reduction in crying time was significant (P < 0.01) even during first week of initiation of therapy. We conclude that L. reuteri (DSM 17938) reduces daily crying time and maternal depression during infantile colic. We suggest L. reuteri may be a safe and efficacious option for reducing infant colic.

This study evaluated the effect of a partly fermented infant formula (using the bacterial strains Bifidobacterium breve C50 and Streptococcus thermophilus 065) with a specific prebiotic mixture (short-chain galacto-oligosaccharides (scGOS) and long-chain fructo-oligosaccharides (lcFOS; 9:1)) on the incidence of gastrointestinal symptoms, stool characteristics, sleeping and crying behaviour, growth adequacy and safety. Two-hundred infants ≤28 days of age were assigned either to experimental infant formula containing 30% fermented formula and 0.8 g/100 mL scGOS/lcFOS or to non-fermented control infant formula without scGOS/lcFOS. A group of breastfed infants served as a reference. No relevant differences in parent-reported gastrointestinal symptoms were observed. Stool consistency was softer in the experimental versus control group with values closer to the breastfed reference group. Daily weight gain was equivalent for both formula groups (0.5 SD margins) with growth outcomes close to breastfed infants. No clinically relevant differences in adverse events were observed, apart from a lower investigator-reported prevalence of infantile colic in the experimental versus control group (1.1% vs. 8.7%; p < 0.02). Both study formulae are well-tolerated, support an adequate infant growth and are safe for use in healthy term infants. Compared to the control formula, the partly fermented formula with prebiotics induces stool consistencies closer to breastfed infants.

Infant colic is a distressing condition of unknown etiology. An aberrant gastrointestinal microbiota has been associated, and Lactobacillus reuteri supplementation has been shown to reduce crying and/or fussing time (‘crying time’) in some infants with colic. The relationship between L . reuteri gut colonization and crying time has not been examined. We investigated the relationship between L . reuteri colonization and fecal microbiota (microbial diversity and Escherichia coli ), intestinal inflammation, and crying time in infants with colic, using a subset of 65 infants from the Baby Biotics trial, which randomized healthy term infants aged <13 weeks with infant colic to receive probiotic L . reuteri DSM 17938 (1 × 10 8 colony forming units) or placebo daily for 28 days. We observed an overall reduction in median crying time, regardless of L . reuteri colonization status (n = 14 colonized). There were no differences in E . coli colonization rates or densities, microbial diversity or intestinal inflammation by L . reuteri colonization status. We found that L . reuteri density positively correlated with crying time, and E . coli density negatively correlated with microbial diversity. As density of L . reuteri was associated with increased crying time, L . reuteri supplementation may not be an appropriate treatment for all infants with colic.

To explore whether sexual intercourse is beneficial to the clinical outcome of SWL for ureteral calculi of 7-15 mm in the distal ureter. Between March 2016 and January 2017, 225 patents with a stone (7-15 mm) in distal ureter were randomly divided into three groups after SWL: Group 1 was asked to have sexual intercourse at least three times a week, Group 2 was administered tamsulosin 0.4 mg/d and Group 3 was received standard therapy alone and served as the controls. Stone free rate, time to stone expulsion, pain score at admission, number of hospital visits for pain and steinstrasse were recorded in 2 weeks. 70 patients in Group 1, 71 patients in Group 2 and 68 patients in Group 3 were enrolled to the study. At the end of the first week and the second week, the stone free rates for Group 1 (68.6%, 80.0%) and Group 2 (69.0%, 81.7%) were approximately the same, but were significantly higher than Group 3 (50.0%, 63.2%) (P = .031, P = .022). The VAS scores of Groups 1 and 2 were slightly higher than those of Group 3 (P = .233). The number of patients in Group 3 who visited the emergency room for pain was significantly higher than in the other two groups (P = .015). At the end of the second week, the incidence of steinstrasse in Groups 1 and 2 was significantly lower (2.9%, 2.8% vs 11.8%) (P = .034). At least three sexual intercourses per week after SWL can effectively improve the stone free rate, reduce the formation of steinstrasse and relieve renal colic. It provides a choice for urologists in the SWL treatment of lower ureteral calculi.

Despite its benign, natural course, colic is a significant problem in infants and imparts a psychological, emotional, and physical burden to parents. Dicyclomine hydrochloride is the only pharmacological treatment for infantile colic that has been consistently effective. Unfortunately, 5% of infants treated with dicyclomine hydrochloride develop serious side effects, including death. Fennel seed oil has been shown to reduce intestinal spasms and increase motility of the small intestine. However, there have not been any clinical studies of its effectiveness. To determine the effectiveness of fennel seed oil emulsion in infantile colic. Randomized placebo-controlled trial. Two large multi-specialty clinics. 125 infants, 2 to 12 weeks of age, who met definition of colic. Fennel seed oil emulsion compared with placebo. Relief of colic symptoms, which was defined as decrease of cumulative crying to less than 9 hours per week. The use of fennel oil emulsion eliminated colic, according to the Wessel criteria, in 65% (40/62) of infants in the treatment group, which was significantly better than 23.7% (14/59) of infants in the control group (P < 0.01). There was a significant improvement of colic in the treatment group compared with the control group [Absolute Risk Reduction (ARR) = 41% (95% CI 25 to 57), Number Needed to Treat (NNT) = 2 (95% CI 2 to 4)]. Side effects were not reported for infants in either group during the trial. Our study suggests that fennel seed oil emulsion is superior to placebo in decreasing intensity of infantile colic.

Development of new infant formulas aims to replicate the benefits of breast milk. One benefit of breast milk over infant formulas is greater gastrointestinal comfort. We compared indicators of gastrointestinal comfort in infants fed a whey-predominant formula containing long-chain polyunsaturated fatty acids, galacto-oligosaccharides and fructo-oligosaccharides, and infants fed a control casein-predominant formula without additional ingredients. The single-centre, prospective, double-blind, controlled trial randomly assigned healthy, full-term infants (n=144) to receive exclusively either experimental or control formula from 30 days to 4 months of age. A group of exclusively breast-fed infants served as reference (n=80). At 1, 2, 3, and 4 months, infants' growth parameters were measured and their health assessed. Parents recorded frequency and physical characteristics of infants' stool, frequency of regurgitation, vomiting, crying and colic. At 2-months, gastric emptying (ultrasound) and intestinal transit time (H2 breath test) were measured, and stool samples collected for bacterial analysis. Compared to the control (n=69), fewer of the experimental group (n=67) had hard stools (0.7 vs 7.5%, p<0.001) and more had soft stools (90.8 vs 82.3%, p<0.05). Also compared to the control, the experimental group's stool microbiota composition (mean % bifidobacteria: 78.1 (experimental, n=17), 63.7 (control, n=16), 74.3 (breastfed, n=20)), gastric transit times (59.6 (experimental, n=53), 61.4 (control, n=62), 55.9 (breast-fed, n=67) minutes) and intestinal transit times (data not shown) were closer to that of the breast-fed group. Growth parameter values were similar for all groups. The data suggest that, in infants, the prebiotic-containing whey-based formula provides superior gastrointestinal comfort than a control formula.

To investigate evidence for the treatment of childhood colic by supplementing Lactobacillus reuteri in infants breastfed with breast milk. The study was conducted according to the PRISMA protocol. The databases used for acquiring data were PubMed and Web of Science, applying MeSH terms and free terms. Meta-analysis was conducted using Stata ™ 12.0. The risk of bias was evaluated by the Review Manager (RevMan) 5.3 tool, and the strength of evidence was assessed by the Grading of Recommendations Assessment, Development and Evaluation (GRADE). Ten clinical trials were included in the review. The administration of L. reuteri (DSM 17938 or ATCC55730) was tested in infants (n = 248) versus the control/placebo group (n = 229). Eight articles were included in the meta-analysis. There was a significant response in reducing crying time (minutes/day) and treatment effectiveness (reduction ≥ 50% in average daily crying time) in the first week (p = 0.001 and p = 0.003, respectively). These results were similar in the second, third weeks (p < 0.001 for both outcomes) and fourth weeks (p<0.001 and p = 0.002, respectively). The risk of bias was low for the majority of the studies. Confidence in evidence was considered very low for crying time and low for effectiveness treatment. The evidence shows that the administration of Lactobacillus reuteri to babies fed with breast milk reduces the crying time in babies diagnosed with colic. But our confidence in the effect estimate is limited. •There was a reduction in gastrointestinal symptoms in breastfed babies by mothers who received probiotics.•The use of L. reuteri for the treatment of infantile colic is effective and promising and does not cause adverse effects.•The use of Lactobacillus reuteri in infants who are breastfed significantly reduces the crying time in infants with colic.

Melatonin is secreted during the night in adults but not in infants. It has a hypnotic effect as well as a relaxing effect on the smooth muscle of the gastrointestinal tract. It is plausible that breast milk, which consists of melatonin, may have an effect on improving infants' sleep and reducing infantile colic. Our first goal was to assess the differences in the prevalence and severity of infantile colic and nocturnal sleep between breast-fed infants and supplement-fed infants. The second was to characterize the profile of melatonin secretion in human breast milk compared to artificial formulas. Ninety-four mothers of healthy 2 to 4-month-old infants filled a questionnaire regarding irritability/potential infantile colic and sleep characteristics. For the second part, we measured melatonin levels in breast milk of five women every 2 h during 24 h and in three samples of commonly used artificial formulas. Exclusively breast-fed infants had a significantly lower incidence of colic attacks ( p  = 0.04), lower severity of irritability attacks ( p  = 0.03), and a trend for longer nocturnal sleep duration ( p  = 0.06). Melatonin in human milk showed a clear circadian curve and was unmeasurable in all artificial milks. Conclusions. Exclusive breastfeeding is associated with reduced irritability/colic and a tendency toward longer nocturnal sleep. Breast milk (nocturnal) consists of substantial melatonin levels, whereas artificial formulas do not. We speculate that melatonin which is supplied to the infant via breast milk plays a role in improving sleep and reducing colic in breast-fed infants compared to formula-fed ones.

Infant colic is a common condition of unknown pathogenesis that brings frustration to families seeking for effective management. Accumulating evidence suggests that some single strains of lactobacilli may play a positive dietary role in attenuation of colic in exclusively breastfed infants. The objective of this study was to evaluate a mixture of two Lactobacillus strains in decreasing infant cry and fuss in this population. Infants aged 4–12 weeks received L. rhamnosus 19070-2 and L. reuteri 12246 in a daily dose of 250 × 106 CFU, 3.33 mg of fructooligosaccharide, and 200 IU of vitamin D3 (84 infants, probiotic group) or just vitamin D3 (84 infants, control group) for 28 days. Cry and fuss time were measured with validated Baby’s Day Diary on days 0 and 28. At baseline, mean (SD) duration of cry and fuss time was comparable in the probiotic and control groups: 305 (81) vs. 315 (90) min., respectively (p = 0.450). On day 28, mean cry and fuss time became statistically different: 142 (89) vs. 199 (72), respectively (p < 0.05). Mean change in cry and fuss time from day 0 through day 28 was −163 (99) minutes in the probiotic and −116 (94) minutes in the control group (p = 0.019). Our findings confirm that lactobacilli decrease cry and fuss time and provide a dietary support in exclusively breastfed infants with colic.